Quick Job Search
Company Name:
Job Type:
Job Seeker Tools
Latest Jobs
Job Seeker Tools
Your Saved Jobs
Build Your Professional Profile
Similar Jobs
GCR Professional Services
Software Test Engineer in Wilton, CT
Lehigh Technical & Professional Service
CPA in Avon, CT
Strategic Health Systems Manager - Northeastern US in Hartford, CT
Dick's Sporting Goods
Holiday Sales Associate (All positions) in Canton, CT
Embedded Software Engineer in Woodstock, CT
Machine operator in Ansonia, CT
Maintenance Mechanic in Danielson, CT
Featured Employers
Sr Manager Validation, Pharma Services Group
Company: Thermo Fisher Scientific
Location: Bridgeport, CT
Employment Type: Full Time
Date Posted: 10/17/2020
Expire Date: 12/06/2020
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Manufacturing and Production, Executive Management, Quality Control, Research & Development
Job Description
Sr Manager Validation, Pharma Services Group

In this key role, you will be part of a technical professional team involved in the corporate Global Technical Operations (GTO). GTO is dedicated to the oversight of the development and commercialization of quality drug products. You will be viewed as a subject matter expert on requirements, methodology, industry standards, and best practices of Validation within the Pharmaceutical Industry. Your ability to use a team approach for managing initiatives in quality, validation, and compliance is a critical success factor. You will interface with site and corporate Engineering, Manufacturing, Technical Operations, Quality, Product Development, PPI, Validation, and other departments as needed in the accomplishment of his/or her objectives.

Primary Responsibilities

  • Manage and support multi-site diagnostic activity to identify gaps in validation processes, practices, systems, and talent. Drive actions and provide expertise to develop solutions across the network that address gaps.
  • Work closely with Validation, Quality, Engineering, Technical Operations, and other functions to define and implement standards, guidelines, and best practices for Validation. This includes Process Validation, Cleaning Validation, Commissioning and Qualification (C&Q), and others.
  • Drive improvement/standardization in key Validation areas including Strategy, Quality Risk Management (QRM), Master Planning / Revalidation, Analysis/Testing approaches, and others.
  • Partner with the Continued Process Verification (CPV) Business Process Owner (BPO) and other leaders to ensure a streamlined, well aligned approach across the 3 Stages of Life-Cycle Validation.
  • Manage initiatives to develop and implement operating systems, process flows, and management tools for effectiveness throughout the Validation function.
  • Work with Corporate Quality, Technical staff, and Audits to develop and manage sustainability assessments and compliance audits to ensure effective Validation and to drive improvement.
  • Partner with PPI and other functions to drive continuous improvement
  • Demonstrate highly effective oral and written communication skills and strong leadership ability. Be able to engage leadership and teams at different levels in the organization.


  • Bachelors or Masters in chemical/mechanical/pharma engineering/science or related field
  • MS and 5+ yrs. of relevant work experience, Bachelors and 10+ years of relevant work experience


  • 8 yrs. of proven leadership ability including managing teams, people, and technical projects
  • Proficient knowledge of FDA regulatory requirements, quality systems, data integrity requirements, and cGMP for validation and pharmaceutical operations.
  • In Depth of knowledge and proven performance in validation for pharmaceutical operations.
  • Knowledge of C&Q, ISPE Baseline Guide, GAMP, and industry best practices is preferred.
  • Strong written and oral communication skills. Able to write detailed technical reports.
  • Ability to work cross-functionally and at multiple levels of the organization.
  • Knowledge of pharmaceutical business processes and equipment.
  • Professional CQE or Lean Six Sigma certification not required but preferred.
  • Ability to travel a minimum of 50% on an annual basis.
Contact Information
Company Name: Thermo Fisher Scientific
Website: https://thermofisher.contacthr.com/...
Company Description:

Apply Now | Forward Job to a Friend | More Jobs From This Employer